Efficiency and Safety of Pleural Biopsy Methods in the Diagnosis of Pleural Diseases

Medical Thoracoscopy Clinical Trial

Official title:

How Should be Invasive Diagnostic Algorithm in Pleural Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03153501
• Other study ID #: PR-11-01-31-21
• Status: Completed
• Phase: N/A
• First received: May 4, 2017
• Last updated: May 12, 2017
• Start date: February 8, 2011
• Est. completion date: April 30, 2017

Study information

• Verified date: May 2017
• Source: Eskisehir Osmangazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Image-guided pleural biopsies, both ultrasound (US) or computed tomography (CT) guided, and medical thoracoscopy are important in the diagnosis of pleural disease. However, no consensus exists regarding which biopsy methods are appropriate for specific procedures.

In this prospective study, the investigators aimed to compare CT-scan guided pleural biopsy using an Abrams' needle (CT-ANPB) with US-assisted pleural biopsy using a cutting needle (US-CNPB)and medical thoracoscopy with respect to both diagnostic yield and safety.

Description:

The primary end point of this study was the determination of the sensitivity and the complication rates of the invasive methods, Abrams needle pleural biopsy, tru-cut needle pleural biopsy, medical thoracoscopy with respect to the diagnosis of pleural disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: April 30, 2017
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients with pleural diseases

Exclusion Criteria:

• Patients with other lung diseases

Related Conditions & MeSH terms

• Diagnosis of Pleural Diseases
• Medical Thoracoscopy
• Pleural Diseases

Intervention

Diagnostic Test:
• CT-guided Abrams needle biopsy, US-guided cutting needle, medical thoracoscopy

Locations

Country	Name	City	State
Turkey	Eskisehir Osmangazi University Medical Faculty	Eskisehir
Turkey	ESOGU Medical Faculty Department of Chest Diseases	Eskisehir	Meselik - Eskisehir

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Kim SJ, Choi SM, Lee J, Lee CH, Lee SM, Yim JJ, Yoo CG, Kim YW, Han SK, Park YS. Medical Thoracoscopy in Pleural Disease: Experience from a One-Center Study. Tuberc Respir Dis (Seoul). 2017 Apr;80(2):194-200. doi: 10.4046/trd.2017.80.2.194. Epub 2017 Mar 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic efficiencies of pleural biopsy methods; CT-guided Abrams needle, US-guided cutting needle and medical thoracoscopy in the diagnosis of pleural diseases: The sensitivity, specificity, negative predictive value and positive predictive value.	The sensitivity, specificity, negative predictive value and positive predictive value of computed tomography guided Abrams needle pleural biopsy, ultrasonography guided cutting needle biopsy and medical thoracoscopy techniques in the diagnosis of pleural diseases.	5 years
Primary	Safety of pleural biopsy methods; CT-guided Abrams needle, US-guided cutting needle and medical thoracoscopy in the diagnosis of pleural diseases: Rate of side effects.	Rate of side effects comparing to each other for computed tomography guided Abrams needle pleural biopsy, ultrasonography guided cutting needle biopsy and medical thoracoscopy techniques in the diagnosis of pleural diseases.	5 years